Repair of Articular Osteochondral Defect

Not Applicable

• Conditions: Osteochondritis Dissecans
• Interventions: Device: Biphasic osteochondral composite

• Registration Number: NCT01409447
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Detailed Description

Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Last Update Submitted: 2011-08-19
• Last Update Posted: 2011-08-22
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age: 18 ~ 60 years
• Articular cartilage defect of the knee
• Diagnosis by X-ray and/or MRI, Arthroscopy
• Confined area: diameter < 3 cm
• Full layer cartilage damage

Read More

Exclusion Criteria

• Pregnancy
• Nonunion of fracture around the knee
• Diffuse degenerative arthropathy of the knee
• Diffuse cartilage pathology due to
• Rheumatism: rheumatoid, psoriatic, ...
• Metabolic disorder: gouty, hemorrhagic, ...
• Stiff knee from any reason
• Flexion < 130˚
• Extension loss > 20˚

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biphasic osteochondral composite	Biphasic osteochondral composite	feasibility study for the new medical device \& technique

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score	1 Year

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan